RecruitingNot ApplicableNCT06742801

Onyx™ Liquid Embolic IDE Clinical Study

PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature

Sponsor

Medtronic Endovascular

Enrollment

119 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Trauma Ulcer GI Bleed Hemorrhage Peripheral Arterial Hemorrhage

Summary

The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Onyx™ Liquid Embolic System for people with gi bleed, hemorrhage, and other related conditions. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOnyx™ Liquid Embolic System

The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.

Locations(18)

Mayo Clinic

Phoenix, Arizona, United States

University of California, Irvine

Irvine, California, United States

Stanford Medical Center

Palo Alto, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Yale New Haven

New Haven, Connecticut, United States

University of Chicago

Chicago, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Masschusetts General Hospital

Boston, Massachusetts, United States

CHI Health Creighton University Medical Center-Bergan-Mercy

Omaha, Nebraska, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Albany Medical Center

Albany, New York, United States

The Mount Sinai

New York, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Univ Of Texas Southwestern

Dallas, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06742801

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